Regulatory update: Hepatitis B hold lifted for Arbutus drug and Ultomiris receives accelerated approval

A regulatory update notes that the FDA has removed the clinical hold on Arbutus Biopharma's hepatitis B candidate, clearing the path for the company to resume development after a prolonged review.

In a separate decision, the agency granted accelerated approval to Ultomiris, allowing the therapy to reach patients more quickly based on surrogate endpoints.

The briefing also mentioned upcoming announcements from Biohaven, Arcus Biosciences, and a collaboration between Boehringer Ingelheim and Microsoft, though details were not disclosed.